Study Status
Show Details
Nickname
Protocol Nickname
Study Status
Active
Site Activation
176 / 190 (92.6%)
Participant Enrollment
1301 / 1300 (100.1%)
Protocol Row Id
1-1G9113
Studyid
AA-AA-000-0000
Protocol Title
Protocol Title
Nickname
Protocol Nickname
Protocol Type
Investigator Sponsored
Phase
P3
Num Plan Site
190
Num Site Actl
176
Est Fpfv
2003-01-01
Act Fpfv
2003-01-01
Est Lplv
2021-06-01
Act Lplv
2021-06-01
Est Lpfv
2020-06-01
Act Lpfv
2020-06-01
Study Status
Active
Num Plan Subj
1300
Num Enrolled Subj M
1301
Protocol Indication
Protocol Indication
Product
Product
Therapeutic Area
Therapeutic Area
Protocol Product Number
123
X Rbm Flg
Y
Site Target
190
Participant Target
1300
Participants Enrolled
1301
Active Participant Count
1301
Sites Enrolled
176
Percent Sites Activated
92.6
Site Activation
176 / 190 (92.6%)
Percent Participants Enrolled
100.1
Participant Enrollment
1301 / 1300 (100.1%)
Percent Participants Active
100
Active Participants
1301 / 1301 (100%)
Study Overview
As of 2025-03-21, AA-AA-000-0000 has 1301 participants enrolled across
176 sites. 118 Site-KRI combinations have been flagged across 71 sites
as shown in the Study Overview Table above.
38 sites have at least one red KRI
71 sites have at least one red or amber KRI
105 sites have neither red nor amber KRIs
Results
Adverse Event Rate Simaerep
Adverse Event Rate ZScore
Protocol Deviation Rate
Protocol Deviation Rate ZScore
Metric Details
Type
ID
GroupLevel
Abbreviation
Metric
Numerator
Denominator
Model
Score
AnalysisType
Threshold
nMinDenominator
Priority
MetricID
Analysis
kri0001
Site
AE-Simaerep
Adverse Event Rate Simaerep
Adverse Events
Visit
bootstrap-simaerep
Over/Under-Reporting Probability
identity
-0.99, -0.95, 0.95, 0.99
1
0
Analysis_kri0001
Analysis
kri0002
Site
AE-ZScore
Adverse Event Rate ZScore
Adverse Events
Visit
Normal Approximation
Adjusted Z-Score
rate
-2,-1,2,3
1
0
Analysis_kri0002
Analysis
kri0003
Site
PD-Simaerep
Protocol Deviation Rate
Protocol Deviation Simaerep
Visit
bootstrap-simaerep
Over/Under-Reporting Probability
identity
-0.99, -0.95, 0.95, 0.99
1
0
Analysis_kri0003
Analysis
kri0004
Site
PD-ZScore
Protocol Deviation Rate ZScore
Protocol Deviation
Visit
Normal Approximation
Adjusted Z-Score
rate
-2,-1,2,3
1
0
Analysis_kri0004